Sotylize

Black Box Warnings

Hospitalize patient at least 3 days while on maintenance dose in facility that provides cardiac resuscitation, continuous ECG monitoring, and estimated CrCl

Calculate CrCl before initiating sotalol therapy

Sotalol has proarrhythmic effects and can cause life-threatening ventricular tachycardia associated with QT interval prolongation; reduce dose, prolong infusion time, or discontinue use if QTc is greater than 500 msec during therapy

Do not substitute sotalol for sotalol AF, because of significant differences in labeling (ie, patient package insert, dosing administration, safety information)

Betapace AF indicated for atrial fibrillation; Betapace indicated for ventricular arrhythmias

Contraindications

Asthma, sinus bradycardia, sick sinus syndrome or 2°/3° AV block unless pacemaker in place

Prolonged QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, hypersensitivity, hypokalemia (<4 mEq/L), hypomagnesemia

Betapace AF & IV: CrCl <40 mL/min

Easily reversible atrial fibrillation/flutter

QT interval >450 ms when treating for AFIB

Cautions

May worsen arrhythmias

May cause or worsen congestive heart failure

Long-term administration of beta blockers should not be routinely discontinued before major surgery; however, impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

Formulations indicated for ventricular and atrial arrhythmias are different (eg, Betapace versus Betapace AF); follow instructions as applicable

Antacids given 2 hours or less before sotalol may reduce bioavailability

Reduce or discontinue therapy if QT prolongation, bradycardia, AV block, hypotension, worsening or heart failure occur

Do not discontinue abruptly; acute exacerbation of coronary artery disease may occur upon abrupt cessation of therapy

Correct any electrolyte disturbances

May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor

Mechanism of Action

Antiarrhythmic: Class II (beta blockade) and class III (action potential prolongation) properties

Has adrenoceptor-blocking effect and markedly prolongs action potential and repolarization

Absorption

Bioavailability: 90-100%

Onset: IV, 1-2 hr; 5-10 min for ongoing VT

Peak plasma time: 2.5-4 hr

Distribution

Protein bound: None

Vd: 1.2-2.4 L/kg

Metabolism

None

Elimination

Half-life: Adults, 12 hr; children, 9.5 hr; prolonged in renal impairment

Excretion: Urine (unchanged)

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• slow heartbeats;
• a light-headed feeling, like you might pass out;
• trouble breathing;
• severe diarrhea or vomiting, loss of appetite;
• dry mouth, unusual sweating, increased thirst; or
• swelling, rapid weight gain.

Common side effects may include:

• headache;
• dizziness;
• tired feeling; or
• slow heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid taking an antacid within 2 hours before or 2 hours after you take sotalol. Some antacids can make it harder for your body to absorb sotalol.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• slow heartbeats;

• a light-headed feeling, like you might pass out;

• trouble breathing;

• severe diarrhea or vomiting, loss of appetite;

• dry mouth, unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Common side effects may include:

• headache;

• dizziness;

• tired feeling; or

• slow heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take Sotylize. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need an ECG before starting Sotylize and during treatment. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, loose stools (diarrhea), not hungry, or more thirst.
• Do not stop taking Sotylize all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop this medicine as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
• This medicine may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking Sotylize all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
• If you have had a very bad allergic reaction, talk with your doctor. You may have a chance of an even worse reaction if you come into contact with what caused your allergy. If you use epinephrine to treat very bad allergic reactions, talk with your doctor. Epinephrine may not work as well while you are taking this medicine.
• The chance of side effects may be higher in female patients. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sotylize (sotalol oral solution) while you are pregnant.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• To gain the most benefit, do not miss doses.
• Take Sotylize at the same time of day.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take antacids that have aluminum or magnesium in them within 2 hours of Sotylize.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Sotylize.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Fast or slow heartbeat.
• A new or worse heartbeat that does not feel normal.
• Feeling very tired or weak.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Sweating a lot.
• Change in eyesight.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Documented Life-Threatening Ventricular Arrhythmia

Sotylize (sotalol hydrochloride) is indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening.

Upon initiation of Sotylize, increasing doses, and prior to chronic outpatient use, evaluated response by a suitable method (e.g., PES or Holter monitoring) at steady-state blood levels of drug.

Limitation of Use

Sotylize may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Sotylize [see Warnings and Precautions (5.1)], including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Delay in Recurrence of Atrial Fibrillation/Atrial Flutter

Sotylize is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Limitation of Use

Because sotalol can cause life-threatening ventricular arrhythmias, reserve it for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotylize.